Quantitative Measurement of Myocardial Perfusion by Cardiac CT in Patients Before and After Coronary-bypass-surgery, Before and After Dilating/Stenting and Before and After Aortic-valve-replacement.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 690
- 试验地点
- 3
- 主要终点
- Change of myocardial perfusion (ml/100g/min) [MPerf]
研究概览
简要总结
It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion. In order to increase (normalize) the reduced perfusion, when a conventional approach failed, coronary bypass surgery, coronary vessel dilatation or stenting are performed. The similar situation with reduced myocardial perfusion may be found in patients with stenosis of the aortic valve, where aortic valve replacement may increase myocardial perfusion by left-ventricular remodelling. However, there is presently no method established to measure myocardial perfusion quantitatively and noninvasively before and after a therapeutic intervention.
Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in ml/100g/min would strengthen the indication for specific therapeutic approach and enable an objective control of effectiveness of the applied therapy.
Hypothesis:
There is a measureable difference in quantitative myocardial perfusion values before (lower) and after (higher) interventional or surgical procedure.
The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients:
- Before and after coronary bypass surgery
- Before and after coronary vessel dilatation/stenting
- Before and after aortic valve replacement.
The investigators will not assign specific interventions to the subjects of these three groups. Therefore, the research is strictly observational.
Design:
Prospective study to measure quantitatively myocardial perfusion in the above mentioned three groups of patients with simultaneous control and registration of all essential, physiological determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial perfusion measurements will be performed directly after the indication for intervention or surgery and on the last day before discharge from hospital.
All the collected data (determinants) inclusively the CT-studies will be anonymised and archived on a local server. The investigators of the University of Medical Computed Sciences and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion measurements and all statistical analysis independently of the CT-studies performing physicians.
详细描述
Reliability of the hypothesis:
On phantom studies simulating myocardial perfusion measurements and in animal studies we could confirm that using advanced CT technology (as e.g. "iCT 256 Brilliance") it is possible to measure myocardial perfusion in absolute values - in ml/100g/min. These myocardial perfusion measurements did not differ from those received by EBCT (Electron Beam Computed Tomography). Based on these experimental results and based on the quantitative measurements of myocardial perfusion in 1500 patients studied by EBCT at the Medical University of Graz the hypothesis may be done that using the above mentioned iCT 256 technology, it should be possible to measure myocardial perfusion quantitatively in a daily clinical practice.
Ethical aspects:
The study will be performed according to the international regulations (ISO 14144:212-01) and in agreement with the "Declaration of Helsinki". After oral and written explanation of the planned study and by signing the study agreement by patient and by responsible physician, patients participation is voluntary. The patients participating can leave the study any time without negative sequels for him or her. There is no financial restitution for the patients.
Patients will be informed about (very rare) possible allergoid-toxic reactions during and after intravenous contrast agent application. For possible emergency well trained medical staff and equipment is present. About renal insufficiency: renal failure (creatinin clearance <60ml/min [GFR (Glomerulo Filtration Rate)will be calculated according the Cockroft-Gault-Formula, GFR {ml/min}=((40-age)*weight{kg}*0,85{only for women}]/serum creatinin [mg/dl]*72) above.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •in cohort: Coronary Bypass Surgery:
- •o presence of at least one coronary stenotic lesion above 50% with clinical indication for coronary bypass surgery
- •in cohort: Coronary Stenting: o presence of at least one coronary stenotic lesion above 50% with indication for coronary vessel dilatation/stenting
- •in cohort: Aortic Valve Replacement
- •o presence of aortic valve disease (stenosis) with clinical indication for aortic valve replacement without coronary vessel stenosis above 50%
- •for all three cohorts:
- •list of medication timely related to the procedure
- •signed informed consent
排除标准
- •for all three cohorts:
- •intolerance to contrast agent
- •multiple myeloma, pheochromocytoma, thyroid dysfunction, acute infection
- •renal failure
- •severe arrhythmia
- •pregnancy
- •reduction of cognitive capabilities to understand the purpose and the extent of the study
- •participation in a medical-scientific study using X-rays in the last ten years
- •lack of Russian knowledge to fill the forms
- •lack of signed study agreement -
结局指标
主要结局
Change of myocardial perfusion (ml/100g/min) [MPerf]
时间窗: 2015 - 2019
after indication for and before intervention or surgery and after intervention or surgery one day before discharge
次要结局
- Composition of parameters influencing the complexity of myocardial perfusion regulation: Heart-rate, blood-pressure, rate-pressure-product, left ventricular haemodynamic parameters(2015 - 2019)
研究者
Rainer Rienmueller, M.D.
em.Univ.Prof.Dr.med.
Bakulev Scientific Center of Cardiovascular Surgery